The ready-to-use liquid botulinum toxin treatment requires no reconstitution. Phase III trials showed improvements in frown lines, with some patients maintaining results for up to six months.

The Chinese National Medical Products Administration (NMPA) has approved Galderma’s Relfydess (relabotulinumtoxinA) for the temporary improvement of moderate-to-severe glabellar lines, or frown lines, in adults, the company announced.

Galderma’s says Relfydess is the first and only ready-to-use liquid neuromodulator developed with PEARL Technology, designed to deliver a complex-free molecule and optimized for simple volumetric dosing without reconstitution. The approval expands Galderma’s injectable aesthetics portfolio into China and follows authorizations in more than 35 markets worldwide, including the European Union, the United Kingdom, and Australia.

Clinical Trial Results

The NMPA approval is based on data from a local phase III study conducted in China, as well as the global READY (RElabotulinumtoxin Aesthetic Development studY) clinical trials, which included more than 2,300 participants.

Across the trials, Relfydess demonstrated:

  • A composite 2-grade or greater improvement responder rate at Month 1 of 82.9% in READY-1 and 72.4% in the China study, compared with 0% and 1.6% for placebo, respectively
  • Rapid onset of action, with 39% of patients reporting improvements in frown lines from day one in READY-1
  • Sustained results lasting through six months in up to 75% of patients, who did not return to baseline severity in READY-1
  • A favorable safety profile, with a low incidence of treatment-related adverse events that were predominantly local or expected effects such as injection-site reactions, headache, and eyelid ptosis

A composite responder was defined as a subject with a glabellar line severity score of 0 or 1 and an improvement of at least 2 grades from baseline on both the glabellar line investigator live assessment and glabellar line subject live assessment.

Market Context

Insights from a Galderma survey on anti-wrinkle treatments indicate that 97% of surveyed patients in China plan to maintain or increase their use of such treatments in the future. The survey also found that 88% of Chinese patients ranked natural-looking results as one of their top three treatment benefits, and 86% ranked long-lasting results of up to six months in their top three.

Relfydess is developed and manufactured at Galderma’s Aesthetic Center of Excellence in Uppsala, Sweden.

“Relfydess represents a breakthrough in neuromodulation, the first in decades. As a clinician, I have seen patients increasingly seek treatments that fit seamlessly into their lifestyles, delivering both rapid onset and long-lasting results. With its ready-to-use liquid formulation requiring no reconstitution, Relfydess also offers a new level of convenience and innovation. I am delighted to bring this treatment to aesthetic patients in China and help usher in a new era in neuromodulation,” says Wu Yan, chief physician of the dermatology department at Peking University First Hospital, in a release.

“The approval of Relfydess in China marks a significant milestone for Galderma and reinforces our commitment to bringing differentiated, science-based innovations to patients and healthcare professionals worldwide. With approvals in more than 35 markets globally, Relfydess continues to build strong momentum, and we are excited to now bring it to patients in China, one of the world’s biggest and most dynamic aesthetics markets,” says Flemming Ørnskov, MD, MPH, CEO of Galderma, in a release.

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